5444-0-200

GUDID 07613252133544

CMF CUSTOMIZED IMPLANT KIT MEDIUM

Howmedica Osteonics Corp.

Cranioplasty plate, non-alterable

• Primary Device ID: 07613252133544
• NIH Device Record Key: f71ae358-8b6e-4327-bcc3-d331c4847e85
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5444-0-200
• Catalog Number: 5444-0-200
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252133544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103010

FDA Product Code

• KKY: MATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

Devices Manufactured by Howmedica Osteonics Corp.

• 07613327296969 - Trident X3 Insert: 2026-01-29 Trident X3 0 Degree Polyethylene Insert
• 07613327296983 - Trident X3 Insert: 2026-01-29 Trident X3 0 Degree Polyethylene Insert
• 07613327296990 - Trident X3 Insert: 2026-01-29 Trident X3 0 Degree Polyethylene Insert
• 07613327297027 - Trident X3 Insert: 2026-01-29 Trident X3 0 Degree Polyethylene Insert
• 07613327297041 - Trident X3 Insert: 2026-01-29 Trident X3 0 Degree Polyethylene Insert
• 07613327297058 - Trident X3 Insert: 2026-01-29 Trident X3 0 Degree Polyethylene Insert
• 07613327297065 - Trident X3 Insert: 2026-01-29 Trident X3 0 Degree Polyethylene Insert
• 07613327338751 - Trident X3 Insert: 2026-01-29 Trident X3 10 Degree Polyethylene Insert